Medical device company NESS Neuromuscular Electrical Stimulation Systems Ltd. (see http://ishitech.co.il/0504ar2.htm) announced that it received US Food and Drug Administration (FDA) approval to market its NESS L300 device for moving paralyzed legs in the US. The company's announcement follows a previous one two weeks ago in which it reported it received European CE Mark certification for its product.
The company estimates the market for its product in the US to be worth in excess of $2 billion, and said it expects a substantial increase in sales following the FDA approval and the launch of marketing in the US. NESS CEO Shmuel Shany said the company now had a unique solution with this kind of product and that it would probably have sales totalling a few million dollars in coming years.
Shany added that the product was designed for use by rehabilitation centers and private patients. "In the US, there 2,000-3,000 rehabilitation centers for head injuries and these centers can buy the devices and supply them to patients. The equipment can also be used by private patients in their own homes." The company intends to sell the L300 at $6,000 per unit, and is in talks with medical insurance providers to finance the purchase for private users who can't afford to buy it themselves.
NESS's main investor is Teuza - A Fairchild Technology Venture Ltd. (TASE:TUZA) with a 34% stake. Other investors are businessman Alfred Mann, BG Technologies and Applications (the technology transfer company of Ben Gurion University of the Negev), Johnson and Johnson Development Corporation, ABN Amro Capital, Dow Corporate Venture Capital, Life Sciences Partner, and Israel-United States Binational Industrial Research and Development Foundation (BIRD-F). The company will distribute the product in the US through a joint NESS-Alfred Mann subsidiary.